First Two-Drug Regimen for HIV Gets USFDA Approval

The therapy called Juluca reduces the number of drugs for HIV and its side effects. It is available for patients who have been on a stable regimen for six months.

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Antiretroviral therapy for HIV treatment helps to restore the functions of the immune system and prolongs the lifespan of the patient

‘The USFDA approved Juluca, the first complete treatment containing only two drugs to treat certain patients human immunodeficiency virus type 1 (HIV-1)’

Highlights:

The US FDA approves the first two-drug treatment for HIV
The drug, Juluca is a combination of two other drugs - dolutegravir and rilpivirine
Juluca helps maintain the undetectable viral loads of patients who have already been on a consistent antiretroviral regimen

The US Food and Drug Administration (USFDA) approved the first two-drug regimen to treat HIV type 1. The treatment called Juluca can reduce the side effects of current treatments that combine three or four drugs.

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Juluca - Complete Treatment for HIV Type 1

Juluca is a fixed-dose tablet that combines two active ingredients previously approved by the FDA, dolutegravir, and rilpivirine. The new treatment prevents the HIV virus from making copies of itself. The drug is available for patients who have already been on a stable regimen for at least six months.

Juluca is the first out of three viral two-drug regimens to receive USFDA approval after successful clinical trials. Studies on Juluca found that patients who switched to the two-drug regimen from their previous therapy were able to maintain undetectable viral load even without a third antiretroviral drug.

People with HIV receive a standard treatment which involves a number of antiretroviral therapies that combine three drugs. These therapies can extend and improve the quality of lives of people with HIV. But, a standard treatment for HIV requires strict dosage regimen that can cause side effects like nausea, insomnia and may also damage vital organs like the heart, kidneys, and liver.

The standard treatment for HIV like Truvada may weaken the immune system and increase the risk of transmitting the HIV if not taken every day at the exact same time. The benefits of these standard treatments outweigh their risks, but the side effects have led to the development of innovative therapies like Juluca.

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Clinical Trials of Juluca

Two clinical trials of Juluca were conducted to study its safety and efficacy in 1,024 participants whose viral load was suppressed on their current antiretroviral drugs. The participants were randomly assigned to continue their antiretroviral treatment or to switch to Juluca. The results showed that Juluca was effective in maintaining a lower viral load compared to those who continued their antiretroviral treatment.

“The ‘one-pill, once-a-day combination’ provides people living with HIV the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen,” said John Pottage, ViiV’s chief scientific officer.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.

The recommended dosage of Juluca is one tablet taken orally, once a day with a meal. One tablet of Juluca contains 50mg of dolutegravir and 25mg of rilpivirine.

Juluca belongs to GlaxoSmithKline Plc’s majority-owned ViiV Healthcare. ViiV’s drug dolutegravir is a part of GSK’s traditional triple-therapy used to control HIV, and rilpivirine is a Johnson & Johnson drug.

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A Note of Caution

Some of the common side effects of taking Juluca were diarrhea and headache and serious side effects include skin rash, allergic reactions, liver problems, depression and mood swings. Juluca should not be given with other antiretroviral drugs and it may also have drug interactions with other common medications.

Reference:

FDA approves first two-drug regimen for certain patients with HIV - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586305.htm)

Source-Medindia